“It seems with the good news today regarding DSM
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Posted On: 10/20/2020 7:49:38 PM
“It seems with the good news today regarding DSMC, that nations would be getting their approvals or emergency approvals or compassionate approval, whatever moving asap and start buying those 300,000 vials Cytodyn has ready to ship.”
The question here is whether or not the FDA equivalents in these interested countries want to see data or not. I’d assume most of them would like to see the data from the S/C trial and won’t approve the drug for S/C population only on the data from the EINDs, the M2M data, and the DSMC’s recommendation. The DSMCs recommendation is good news but I don’t believe any country will approve leronlimab use YET based only on the recommendation. Now, if the interim analysis at the 293 mark is statistically significant and warrants a halt, then yes, countries will beginning lining up to purchase leronlimab.
The question here is whether or not the FDA equivalents in these interested countries want to see data or not. I’d assume most of them would like to see the data from the S/C trial and won’t approve the drug for S/C population only on the data from the EINDs, the M2M data, and the DSMC’s recommendation. The DSMCs recommendation is good news but I don’t believe any country will approve leronlimab use YET based only on the recommendation. Now, if the interim analysis at the 293 mark is statistically significant and warrants a halt, then yes, countries will beginning lining up to purchase leronlimab.
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